FDA Publishes SPL Guide for MoCRA Facility Registration and Product Listings
Client Alert | 1 min read | 11.01.23
On October 13, 2023 he FDA announced that two of the requirements set forth in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)— facility registration and product listing—will be included as part of the Structured Product Labeling (SPL) framework. SPL is a document formatting standard adopted by FDA for exchanging product-related information.
The FDA previously developed Cosmetics Direct, a draft electronic portal for submissions under MoCRA. Companies who will use Cosmetics Direct may submit facility registration information and/or product listings by importing an SPL document, which contains user friendly data entry forms, performs initial validation, creates and saves the SPL submission, and submits the SPL document to FDA for internal processing.
In order to assist those who will be using and uploading SPL documents, the FDA also published a SPL Implementation Guide with technical conformance criteria for SPL documents. According to this Guide, importing an existing SPL document will be useful for bulk submissions, and users will be able to copy a successfully uploaded SPL document as a starting point for their own submission.
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Bid Protests: GAO Reminds Would-Be Protesters – Timing Is Everything
When to file a protest challenging an agency’s corrective action is an issue that has confused protesters for over a decade since GAO’s Domain Name Alliance Registry, B‑310803.2, Aug. 18, 2008, 2008 CPD ¶ 168 decision. In Domain Name, GAO held where a protester essentially challenges the “ground rules” of corrective action, that protest must be filed pre-award or risk being dismissed as untimely. This has led to the proliferation of overly cautious protesters bringing pre-award challenges to corrective actions only to have GAO dismiss such protests as merely anticipating improper agency action and therefore premature. Indeed, the line between a timely and untimely corrective action protest is unclear. And that confusion persists, as evidenced in two recent GAO dismissals—General Dynamics Information Technology, Inc., B-422421.6, B-422421.7, July 17, 2024, and Peraton Inc., B-422409.2, B‑422409.3, July 22, 2024.
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